PE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE 814123008

GUDID 00887868036811

Biomet Orthopedics, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00887868036811
NIH Device Record Keyc2965e63-a68f-498e-9b54-d9862a84ea9c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE
Version Model Number8141-23-008
Catalog Number814123008
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100887868036811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


[00887868036811]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-15
Device Publish Date2017-03-17

On-Brand Devices [PE.R.I.™LOWER EXT PLATE, FIBULA COMPOSITE]

008878680368738141-23-014
008878680368668141-23-013
008878680368598141-23-012
008878680368428141-23-011
008878680368358141-23-010
008878680368288141-23-009
008878680368118141-23-008
008878680368048141-23-007
008878680367988141-23-006
008878680367818141-23-005

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